the monopoly enforcement agenda: a global overview peter maybarduk essential action 29 may 2009...
TRANSCRIPT
The Monopoly Enforcement Agenda:
A Global OverviewPeter MaybardukEssential Action
29 May 2009
Patents and public health
Patents and public health
Patents facilitate monopoly power in medicinesBrand-name companies lock out competition from generics firms
Cost of patented medicines vastly higher than generics
High prices create a terrible access to medicines problem
Patents facilitate monopoly power in medicinesBrand-name companies lock out competition from generics firms
Cost of patented medicines vastly higher than generics
High prices create a terrible access to medicines problem
Access to medicinesAccess to medicines
Generic competition has fueled a revolution in HIV/AIDS treatment98+% cost reduction over ten years: From $10k to near $100
3 million globally on ARTTreatment programs
Generic competition has fueled a revolution in HIV/AIDS treatment98+% cost reduction over ten years: From $10k to near $100
3 million globally on ARTTreatment programs
Competition Competition Price drops average 40-80% with first generic entry, continue to fall with time
Competition between branded and generic, and between generics firms
Competition key to implementing vision of access to medicines for all
Price drops average 40-80% with first generic entry, continue to fall with time
Competition between branded and generic, and between generics firms
Competition key to implementing vision of access to medicines for all
A global monopoly enforcement agendaA global monopoly enforcement agenda
Many new measures worldwide protect patent and copyright monopolies under guise of fighting counterfeits and “piracy.”
See Susan Sell, “The Global IP Upward Ratchet.”
See Kevin Outterson, “Import Safety Rules.”
See Essential Action, “Survey.”
Many new measures worldwide protect patent and copyright monopolies under guise of fighting counterfeits and “piracy.”
See Susan Sell, “The Global IP Upward Ratchet.”
See Kevin Outterson, “Import Safety Rules.”
See Essential Action, “Survey.”
Table: How PHrMA confuses monopoly
enforcement and public health needs
Table: How PHrMA confuses monopoly
enforcement and public health needs
Venn diagram: The actual
relationship between drug
quality, fake medicines and
the enforcement agenda
MSF: “the majority of poor drugs [are] genuine, but substandard drugs, and not the result of
counterfeiting” (2008)
Enforcement agendaEnforcement agendaSerious anti-competitive effects and public health costsSeeks to confuse public, reduce confidence in generics
Can chill investment, international tradeMay snare non-infringing competitors in its net
Places enforcement burden on publicMore aggressive patent enforcement generally
Seize-and-destroy rather than damages
Yet, some anti-counterfeiting measures may protect public health.
Question for today: How do we respond?
Serious anti-competitive effects and public health costsSeeks to confuse public, reduce confidence in generics
Can chill investment, international tradeMay snare non-infringing competitors in its net
Places enforcement burden on publicMore aggressive patent enforcement generally
Seize-and-destroy rather than damages
Yet, some anti-counterfeiting measures may protect public health.
Question for today: How do we respond?
Global IP enforcement initiatives
Global IP enforcement initiatives
Major international organizations: WHO, INTERPOL, WCO, APEC, Postal Union, more
Accords and Associations: ACTA, G8, Global Congress, Rome Declaration, more
National legislation: Kenya, Uganda, US, EU
National enforcement:US exec branch initiatives, DG Trade, Trainings worldwide
Major international organizations: WHO, INTERPOL, WCO, APEC, Postal Union, more
Accords and Associations: ACTA, G8, Global Congress, Rome Declaration, more
National legislation: Kenya, Uganda, US, EU
National enforcement:US exec branch initiatives, DG Trade, Trainings worldwide
International organizationsInternational organizations
IMPACT (WHO’s International Medical Products Anti-Counterfeiting Taskforce)2006 - Seeks coordinated global response to counterfeits.
Data not well-developed. Joint venture with IFPMA.
IMPACT (WHO’s International Medical Products Anti-Counterfeiting Taskforce)2006 - Seeks coordinated global response to counterfeits.
Data not well-developed. Joint venture with IFPMA.
International organizationsInternational organizations
World Customs Organization: “Secure”Proposed standards to coordinate “a global effort to suppress all kind of intellectual property rights infringements”
“TRIPS-plus-plus”Universal Postal Union (UN Postal Agency)Proposal to control “counterfeit and pirated items sent through the post”
Are customs/postal agents qualified to judge quality or rights infringement?
World Customs Organization: “Secure”Proposed standards to coordinate “a global effort to suppress all kind of intellectual property rights infringements”
“TRIPS-plus-plus”Universal Postal Union (UN Postal Agency)Proposal to control “counterfeit and pirated items sent through the post”
Are customs/postal agents qualified to judge quality or rights infringement?
International organizationsInternational organizations
Anti-counterfeiting and piracy initiatives:Asia-Pacific Economic Cooperation Forum
SPP (US, Canada, Mexico)US-EU Summit (ACTA precursor)OECD report
Anti-counterfeiting and piracy initiatives:Asia-Pacific Economic Cooperation Forum
SPP (US, Canada, Mexico)US-EU Summit (ACTA precursor)OECD report
International organizationsInternational organizations
Pharmaceutical Security Institute2002, now 21 major pharmaceutical companiesTo “collate their fake drug information to cooperate in fighting the racket”
IFPMA is PresidentPSI recorded 76 cases of counterfeiting in 2004; FDA knew of only 58
PSI database thought to be world’s best, but is “not accessible to the WHO, health authorities or the public.”
Pharmaceutical Security Institute2002, now 21 major pharmaceutical companiesTo “collate their fake drug information to cooperate in fighting the racket”
IFPMA is PresidentPSI recorded 76 cases of counterfeiting in 2004; FDA knew of only 58
PSI database thought to be world’s best, but is “not accessible to the WHO, health authorities or the public.”
Accords and AssociationsAccords and
AssociationsACTAG8 declaration
technical assistance pilot programs
4th Global Congress Combating Counterfeiting and Piracy
INTERPOL, WIPO
Visiongain conference major international industry information conference, chaired by IFPMA.
Three annual anti-counterfeiting conferences so far.
Andean-EU FTA, other FTAs
ACTAG8 declaration
technical assistance pilot programs
4th Global Congress Combating Counterfeiting and Piracy
INTERPOL, WIPO
Visiongain conference major international industry information conference, chaired by IFPMA.
Three annual anti-counterfeiting conferences so far.
Andean-EU FTA, other FTAs
ACTA: Anti-Counterfeiting Trade
Agreement
ACTA: Anti-Counterfeiting Trade
AgreementObjective:
“Establish, among nations committed to strong IPR protection, a common standard for IPR enforcement to combat global infringements of IPR particularly in the context of counterfeiting and piracy.”
Really an IP enforcement treaty 3 areas: International Cooperation, Enforcement Practices, Legal Framework
Objective: “Establish, among nations committed to strong IPR protection, a common standard for IPR enforcement to combat global infringements of IPR particularly in the context of counterfeiting and piracy.”
Really an IP enforcement treaty 3 areas: International Cooperation, Enforcement Practices, Legal Framework
ACTAACTA
Especially brazen; simply treats social interests in preventing counterfeits and intellectual property rights as the same. Formula: Trade in counterfeits has increased (alleged), hence IP enforcement must increase.Fallacious (assuming enforcement can be effective, does more to block competition than protect public safety.)
Especially brazen; simply treats social interests in preventing counterfeits and intellectual property rights as the same. Formula: Trade in counterfeits has increased (alleged), hence IP enforcement must increase.Fallacious (assuming enforcement can be effective, does more to block competition than protect public safety.)
ACTA termsACTA terms
Provisional measures to allow authorities to destroy goods without hearing both parties
Border measures; suspend entry of goods
Criminal penaltiesTechnical assistance
Provisional measures to allow authorities to destroy goods without hearing both parties
Border measures; suspend entry of goods
Criminal penaltiesTechnical assistance
National legislationNational legislationUS laws:
Stop Counterfeiting in Manufactured Goods Act, AntiCounterfeiting Amendments of 2004, etc: increase counterfeiting penalties and enforcement powers
PRO-IP Act: Creates IP czar position (still waiting on Obama appointment)
US proposed legislation:IP Enforcement Act, Safeguarding America’s Pharmaceuticals Act, Counterfeit Drug Prevention Act
US laws: Stop Counterfeiting in Manufactured Goods Act, AntiCounterfeiting Amendments of 2004, etc: increase counterfeiting penalties and enforcement powers
PRO-IP Act: Creates IP czar position (still waiting on Obama appointment)
US proposed legislation:IP Enforcement Act, Safeguarding America’s Pharmaceuticals Act, Counterfeit Drug Prevention Act
U.S. National enforcement /
Executive Branch initiatives
U.S. National enforcement /
Executive Branch initiativesUS Chamber of Commerce: Coalition
Against Counterfeiting and PiracyIndustry groupsWant powers to Customs agents, technical assistance to train other governments, IP attaches at American embassies, public awareness campaign
FDA and Dept. of Justice: enforcement cooperation
US Chamber of Commerce: Coalition Against Counterfeiting and PiracyIndustry groupsWant powers to Customs agents, technical assistance to train other governments, IP attaches at American embassies, public awareness campaign
FDA and Dept. of Justice: enforcement cooperation
U.S. enforcement initiatives
U.S. enforcement initiatives
USTR Special 301 Watch listSpecial section on counterfeiting this year; push to empower customs officers to seize goods without court order
National Intellectual Property Rights Coordination CenterRun jointly by Homeland Security and FBI
STOP! Initiative: White HouseNot yet clear if continues under Obama
Global Intellectual Property AcademyInternational training program for judges, enforcement officials
USTR Special 301 Watch listSpecial section on counterfeiting this year; push to empower customs officers to seize goods without court order
National Intellectual Property Rights Coordination CenterRun jointly by Homeland Security and FBI
STOP! Initiative: White HouseNot yet clear if continues under Obama
Global Intellectual Property AcademyInternational training program for judges, enforcement officials
A global industry IP enforcement strategyA global industry IP enforcement strategy
Industries uniting for IP enforcementConflating distinct rights (TM, ©, patent)
Counterfeiting historically applies to trademark alone; piracy an emotive term for copyright infringement - no real application to patents, data protection or trade secrets
Broadly apply “counterfeit,” “piracy”No longer just, “is consumer confused?”Emotionally compelling; effective cover
Misleading agreement names; IP as equal set of rights
Sell IP enforcement as solution to public threats posed by counterfeits
Industries uniting for IP enforcementConflating distinct rights (TM, ©, patent)
Counterfeiting historically applies to trademark alone; piracy an emotive term for copyright infringement - no real application to patents, data protection or trade secrets
Broadly apply “counterfeit,” “piracy”No longer just, “is consumer confused?”Emotionally compelling; effective cover
Misleading agreement names; IP as equal set of rights
Sell IP enforcement as solution to public threats posed by counterfeits
A global industry IP enforcement strategyA global industry IP enforcement strategy
Change nature of patent, copyright, TMChange private rights to public rights
Historically, violation occurs, rightsholder seeks financial compensation, sometimes injunction in court
Place burden on taxpayers to enforce industry monopolies
Prevent alleged violations, deter competition, rather than financial remedies after the factVery dangerous for medicines: stops legitimate generics, also chills financial incentives to trade in generics
Change nature of patent, copyright, TMChange private rights to public rights
Historically, violation occurs, rightsholder seeks financial compensation, sometimes injunction in court
Place burden on taxpayers to enforce industry monopolies
Prevent alleged violations, deter competition, rather than financial remedies after the factVery dangerous for medicines: stops legitimate generics, also chills financial incentives to trade in generics
Industry’s evolving global strategy
Industry’s evolving global strategy
Sell: “Forum shopping”Push each new global opportunity to raise IP enforcement to its limit, then, when challenged, find a new forum.
So far: IP treatiesWTORegional & bilateral trade agreementsCounterfeiting and piracy enforcement
What’s next?
Sell: “Forum shopping”Push each new global opportunity to raise IP enforcement to its limit, then, when challenged, find a new forum.
So far: IP treatiesWTORegional & bilateral trade agreementsCounterfeiting and piracy enforcement
What’s next?
How do we respond? How do we respond?
Industry efforts are more than a piecemeal; there’s a global designHow much deeply planned vs. evolved hard to know
Concerted industry strategy requires concerted, big-picture public interest response
Cross-sectorStrategy to match.
Industry efforts are more than a piecemeal; there’s a global designHow much deeply planned vs. evolved hard to know
Concerted industry strategy requires concerted, big-picture public interest response
Cross-sectorStrategy to match.